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Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer
Complementary Therapies in Medicine (2013) 21, 379—387
Available online at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/ctim
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer夽 Yeon Hee Kim a,1, Hwa Jung Kim b,1, Seung Do Ahn c, Yun Jeong Seo d, So Hee Kim a,∗ a
Department of Nursing, Asan Medical Center, Seoul, Republic of Korea Department of Epidemiology and Biostatistics, Asan Medical Center, Seoul, Republic of Korea c Department of Radiation Oncology, Asan Medical Center, Seoul, Republic of Korea d Dahnworld Korea, Seoul, Republic of Korea Available online 6 July 2013 b
KEYWORDS Breast cancer; Meditation; Anxiety; Fatigue; Quality of life
Summary Objective: To investigate the effects of meditation on anxiety, depression, fatigue, and quality of life in women who are receiving radiation therapy for breast cancer. Design: Randomized, non-program controlled, parallel intervention clinical trial. Setting: The ASAN Cancer Center located in Seoul, Korea. Intervention: The subjects of this study included 102 female breast cancer patients who had undergone breast-conserving surgery; these female patients were randomized into equally assigned meditation control groups, with each group consisting of 51 patients. The test group received a total of 12 meditation therapy sessions during their 6-week radiation therapy period, and the control group underwent only a conventional radiation therapy. Outcome: The tools used to evaluate the effects of meditation were Hospital Anxiety and Depression scale, Revised Piper Fatigue scale, and European Organization for Research and Treatment of Cancer-Quality of Life Core-30. The results were analyzed based on the principles of intention-to-treat analysis, and, as a corollary analysis, per-protocol analysis was conducted. Results: The breast cancer patients who received meditation therapy compared with the nonintervention group saw improvements in reduction of anxiety (p = .032), fatigue (p = .030), and improvement in global quality of life (p = .028). Conclusions: Based on the results of this study, an affirmation can be made that meditation can be used as a non-invasive intervention treatment for improving fatigue, anxiety, quality of life, and emotional faculties of women with breast cancer. © 2013 Elsevier Ltd. All rights reserved.
夽
The Korea Breast Cancer Foundation (KBCF) funded this study. Corresponding author at: 1F West Bldg., Cancer Education Center, Asan Medical Center, 88, Olympic-ro, Songpa-gu, Seoul 138-736, Republic of Korea. Tel.: +82 2 3010 1127; fax: +82 2 3010 1158. E-mail address: [email protected] (S.H. Kim). 1 Both authors contributed equally to this study. ∗
0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.06.005
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Introduction Although radiation therapy, which is conducted as an adjuvant treatment after a breast-conserving surgery, lowers the rate of recurrence and increases disease-free survival rate.1 The patients are subject to experiencing several side effects during the treatment process itself. In particular, along with various physical side effects, as a result of long-term treatment and uncertainty, emotional and social problems such as anxiety and depression can be experienced.2 Additionally, in cases of women with breast cancer, emotional symptoms including depression have been shown to become aggravated depending on the progress of radiation therapy.3 In addition, cancer-related fatigue is a common side effect appealed by 30—80% of cancer patients receiving radiation therapy, regardless of the irradiation area.4 Also, cancer-related fatigue is one of the most common side effects experienced by women breast cancer patients receiving post-surgery adjuvant radiation therapy.5 According to previous studies, in cases of women with breast cancer undergoing radiation therapy treatment, as their treatment progressed, their fatigue levels continued to worsen.6,7 In the last week of treatment their fatigue levels reached the maximum level, and 3—6 months after the completion of treatment the fatigue levels were found to be reverting back to the pretreatment levels; also, the patient’s quality of life was found to be negatively affected.6,7 Moreover, according to the results of a study that examined the symptom clusters associated with treatment for patients with breast cancer, because their depressed mood, cognitive impairment, fatigue, insomnia, and pain all appeared to be related, it is necessary to consider the potential correlation among the symptoms when assessing and planning for the management in breast cancer patients.8 As shown, fatigue, anxiety, and depression are typical psychological and physical side effects experienced by women with breast cancer, and it can be stated that these symptoms require aggressive intervention along with treatment. Meditation is one of the alternative therapies soften practiced in many fields as a non-pharmacological intervention therapy,9 and it is known to be helpful in terms of controlling depression, anxiety, sleep disturbances, pain, fatigue, and stress levels in cancer patients.10,11 Recently (in Korea as well), as an alternative therapy for cancer patients, research on meditation is being attempted, In the case of mindfulness meditation, it is currently one of the methods included as part of the non-pharmacological recommendations of the Version 112 Distress Management Recommendations of the Korea National Cancer Center for the improvement of quality of life in cancer patients. Meditation is diverse in its types and has been developed to suit local features and physical characteristics; therefore, in order for mediation to be studied in Korea so that it can be applied in clinical settings, it would be preferable to use traditional Korean discipline techniques.13 Brain Wave Vibration (BWV) meditation was previously known as ‘‘Body and Brain Holistic Fitness Training’’ or ‘‘Dahn yoga’’14 and is one of the traditional meditation methods in Korea. BWV is believed to be most beneficial when practiced as part of a holistic fitness class in combination with other related yoga-style exercises.15
Y.H. Kim et al. This meditation was developed in South Korea by Il-Chi Lee in the 1980s, and is designed to optimize body and brain health, as well as rebalance the energy systems of the body.16 Although the Brain Wave Vibration meditation has not been attempted on cancer patients, several previous studies17—19 reported its effectiveness in reducing anxiety and dealing with stress. According to a previous study,15 Brain Wave Vibration meditation reported improvement in depression and sleep latency. In the study, ordinary college students were divided into 3 groups and were administered with the Brain Wave Vibration meditation, Iyengar yoga, and mindfulness meditation; the results of these experiments showed that the Brain Wave Vibration group experienced improvement in depression and sleep latency. In another randomized study on the general public, it showed that there were significant effects in reducing stress and enhancing overall positive outlook.20 Based on all of this, by applying the Brain Wave Vibration meditation on women with breast cancer in this study, we attempted to analyze the effects on their anxiety, depression, fatigue, and quality of life.
Participants and methods This study is an open-label, randomized clinical trial investigating the effects that meditation has on anxiety, depression, fatigue, and quality of life in women who are receiving radiation therapy for breast cancer. This study was undertaken only after obtaining approval (IRB approval number: S2011-0179-0002) from the IRB of Asan Medical Center in Seoul, Korea; all participants took part in the study after providing written consent.
Participants Eligible participants included women aged 20 or over with breast cancer, all of whom started radiation therapy after a breast conserving operation, understand the purpose of the study, and agreed to participate. Exclusion criteria included receiving psychiatric treatment, or patients with metastasis or recurrence. Also, those who participated in another study related to distress or quality of life were excluded. The participants in the study were comprised of 102 female cancer patients who were receiving radiation therapy after breast conserving operation at the outpatient unit of ‘‘Asan Medical Center’’ general hospital located in Seoul, Korea.
Intervention The meditation used in this study is Brain Wave Vibration meditation. This is based on the Korean traditional exercise ‘‘Danhak’’ which is a traditional Korean training technique. ‘‘Danhak’’ transformed into a training system that promotes change in mind and body with the brain at the center, and is comprised of simple movements and techniques so that anyone can use it.14,18 This is a modern brain health technique that combines simple movements, such as lightly shaking one’s head side-to-side, movements of a part of the
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy
Fig. 1
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Weekly Meditation Topics
body in a rhythmic fashion, as well as music, action, and positive messages.14,16 In particular, it is a form of meditation with movements that induce focusing on the senses of the body while relaxing the mind and body and relieving negative thoughts in the body through natural rhythmic movements.16 In this study, the test group participated in meditation therapy twice a week during the 6-weeks of radiation therapy period, and the control group underwent the usual radiation-only therapy. The meditation therapy used in this study consisted of 60-min sessions twice a week, and the test group received a total of 12 sessions at twice a week for 6-weeks. This program was conducted for 6-weeks using different topics every week, and the program configuration is shown in Fig. 1. There was no intervention for control group during the study. After the study, we opened same meditation program, and gave them the opportunity to participate.
Outcome measurements and data collection The demographic information and health history of the study participants were collected through their medical records. Data collection for the analysis of the effects of meditation was conducted using a self-reporting questionnaire. The test and control groups were measured within 1-week prior to the commencement of radiation therapy for their anxiety, depression, fatigue, and quality of life status. In the case of the test group, data was collected at the completion of the 6-week radiation therapy and meditation program, and for the control group, they were also tested at the completion of the 6-week radiation therapy. For measuring anxiety and depression, the Hospital Anxiety and Depression scale (HADS)21 was used. The HADS has a total of 14 questions, in which the 7 odd-numbered questions had sub-scales related to anxiety (HAD-A) and the 7 even-numbered questions had sub-scales related to depression (HAD-D). Each question was on a 4-point scale (range of 0—3 points). For measuring fatigue, the Revised Piper Fatigue scale22,23 was used as a tool. There were a total of 19 questions in the questionnaire, and each question was on an 11-point scale (range of 0—10 points). The higher the score, the higher the fatigue level. For measuring the quality of life, a Korean version of the EORTC QLQ-C3024 that consisted
of 30 questions was used. The EORTC QLQ-C30 consisted of 15 scales, including the global quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social) and 8 symptomatic scales (including fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single item (financial difficulties). Of the EORTC QLQ-C30 items concerning the global QOL and functional scale, a higher score means a higher QOL; whereas, for the symptomatic scale and the single item, a higher score means a lower QOL.
Sample size We hypothesized that the meditation changes anxiety and depression levels compared to a control group; according to a previous study,25 the mean difference of anxiety and depression in the experimental group and control group were −1.74 ± 2.49, −.41 ± 2.25, and −2.58 ± 2.75, and −.04 ± 2.08, respectively. The group sample size (51 participants each) achieved 80% power to the similar difference of the previous study25 , with a significance level of .05 using two-sided independent two group t-test (G*Power 3.1 program).
Randomization The study participants, in the order of their agreement to participation in the study, were issued control numbers after consultation. Based on the control numbers, random numbers were generated by the website program — http://randomization.com/. A block of 4 would contain 2A and 2B with a ratio of 1:1. Stratification factors were based on whether the patient subjects had received chemotherapy prior to radiation therapy. One of the authors who did not have contact with patients managed the random numbers.
Statistical methods The primary outcome was a change in anxiety and depression after the intervention in the intention-to-treat (ITT) population. The secondary outcome was change in quality of life. This study was designed to detect between-group
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Fig. 2 Flow chart of the study. Legend: ITT, Intention-To-Treat; PP, Per Protocol.
differences after meditation, a power of 80%, and a type I error rate of 5%. The primary analysis was ITT analysis and involved all patients who were randomly assigned. The per-protocol (PP) analysis was performed as a secondary analysis, and involved participants who participated in more than 9 sessions out of total 12 sessions (Fig. 2). We used an analysis of covariance (ANCOVA) for the measurement of outcomes. The ANCOVA model included as covariates. The ANCOVA model included baseline outcomes as covariates. Baseline measurements were expressed as means and SDs, with independent t-tests used for between-group comparisons of continuous variables, and the fisher’s exact test or Chi-square used for between-group comparisons of categorical variables. The data was analyzed with SPSS 18.0, and a significance level of hypothesis testing was set for p < .05.
Results A total of 252 potential candidates were interviewed and, among these, 102 patients agreed to participate in the study. The number of participants in each group was 51 patients. They were recruited during the period of about 3 months from April 27, 2011 to July 30, 2011. The number of ITT analysis included 51 patients in each group (Fig. 2). There were 40 patients in the meditation group and 43 patients in the control group for the PP analysis. Baseline demographic and clinical characteristics for two groups showed no difference at the 5% significance level except for the emotional function, cognitive function, and social function of the EORTC QLQ-C30 items (Tables 1 and 2).
Anxiety, depression, fatigue, and quality of life In the case of ITT analysis, the result of the effects that meditation has on anxiety, depression, fatigue, and quality of life in women with breast cancer receiving radiation therapy showed the following: the meditation group decreased their anxiety by 1.33 points, whereas the control group increased by .08 points, significantly (p = .032); Also the meditation group decreased their fatigue by .48 points, whereas the control group increased by .60 points (p = .030); however, the change in depression was not significant (p = .184). These results were repeated using the PP analysis and our hypothesis of meditation’s being effective for improving anxiety and fatigue (Table 3). As a result of ITT analysis on the items that correspond to EORTC QLQ-C30, in terms of the global QOL, the meditation group significantly increased 13.29 points, whereas the control group increased 3.69 points (p = .028). These results were also the same using the PP analysis (p = .041) (Table 3). Dyspnea of the meditation group showed a decrease, whereas the control group showed an increase. It was not statistically significant in the ITT analysis (p = 0.090), while it was significant in the PP analysis (p = 0.035) (Table 3). In conclusion, the results of ITT and PP analysis were very similar.
Discussion The present study aimed to investigate the effects of mediation on anxiety, depression, fatigue, and quality of life by subjecting breast cancer patients who currently receive
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy Table 1
383
Baseline characteristics of study participants.
Characteristics
Experimental group (N = 51) N(%), Mean±SD
Control group (N = 51) N(%), Mean±SD
p-valuea
Age
48.12 ± 7.06
46.86 ± 7.74
.394
Level of education High school College Graduate school
25 (49.0%) 21 (41.2%) 5 (9.8%)
29 (56.9%) 19 (37.3%) 3 (5.9%)
.656c
Marital status Married Unmarried Widowed The others
44 (86.3%) 3 (5.9%) 2 (3.9%) 2 (3.9%)
43 (84.3%) 4 (7.8%) 2 (3.9%) 2 (3.9%)
1.000c
Religion Christian Catholic Buddhist None The others
15 (29.4%) 6 (11.8%) 14 (27.5%) 15 (29.4%) 1 (2.0%)
17 (35.4%) 6 (12.5%) 9 (18.8%) 14 (29.2%) 2 (4.2%)
.829c
Regular activity No Yes
17 (33.3%) 34 (66.7%)
15 (29.4%) 36 (70.6%)
.670b
Economic burden Severe Mild None
2 (3.9%) 24 (47.1%) 25 (49.0%)
3 (5.9%) 17 (33.3%) 31 (60.8%)
.361c
Time since diagnosis (months)
5.25 ± 2.45
5.92 ± 3.42
.261
Stage of disease 0 I II III
7 (13.7%) 22 (43.1%) 20 (39.2%) 2 (3.9%)
5 (9.8%) 20 (39.2%) 25 (49.0%) 1 (2.0%)
.725c
Molecular subtype Luminal A Luminal B HER2+ Triple-negative
25 (49.0%) 5 (9.8%) 8 (15.7%) 13 (25.5%)
35 (68.6%) 4 (7.8%) 4 (7.8%) 8 (15.7%)
.216c
Surgery Rt. BCO Lt. BCO Both BCO
22 (43.1%) 29 (56.9%) 0 (0.0%)
22 (43.1%) 28 (54.9%) 1 (2.0%)
1.000c
Chemotherapy AC ACT Not done
13 (25.5%) 19 (37.3%) 19 (37.3%)
19 (37.3%) 11 (21.6%) 21 (41.2%)
.187c
Hormonal therapy Tamoxifen/toremifen Tamoxifen + goserelin Aromatase inhibitor Not done
21 (41.2%) 9 (17.6%) 8 (15.7%) 13 (25.5%)
18 (35.3%) 9 (17.6%) 4 (7.8%) 20 (39.2%)
.384b
HER2 targeted therapy Herceptin Not done
3 (5.9%) 48 (94.1%)
8 (15.7%) 43 (84.3%)
.110b
Abbreviations: BCO, breast conserving operation; AC, doxorubicin + cyclophosphamide; ACT, doxorubicin + cyclophosphamide + docetaxel. a P-value was calculated by t-test, Chi -square test b or Fisher’s exact test c .
384 Table 2
Y.H. Kim et al. Homogeneity of dependent variables before meditation.
Variables
Experimental group (N = 51) Mean ± SD
p-valuea
Control group (N = 51) Mean ± SD
HADS Anxiety Depression
6.84 ± 2.54 7.16 ± 3.38
6.20 ± 2.76 6.82 ± 3.56
.221 .629
PFS Fatigue
3.94 ± 2.11
3.74 ± 1.74
.603
± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
.733 .342 .303 .001 .045 .048 .352 .352 .352 .845 .115 .193 .948 .431 .132
EORTC QLQ C-30 Global quality of life Physical function Role function Emotional function Cognitive function Social function Fatigue Nausea and vomiting Pain Dyspnea Insomnia Appetite loss Constipation Diarrhea Financial difficulties
57.00 68.93 65.00 65.17 67.33 63.33 42.89 10.00 27.67 18.00 35.33 31.33 16.00 11.33 22.67
± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
19.88 18.74 24.80 19.76 23.32 24.51 23.22 14.68 19.52 25.39 28.10 28.89 24.50 19.76 25.59
58.33 72.29 69.94 77.45 75.82 72.22 39.00 10.78 24.84 16.99 26.80 24.18 15.69 8.50 15.69
19.37 16.51 23.10 16.18 18.35 19.91 18.38 15.21 23.18 26.14 25.84 25.89 23.43 16.12 20.39
Abbreviations: HADS, Hospital Anxiety Depression scale; EORTC QLQ C-30, European Organization for Research and Treatment of CancerQuality of Life Core-30; PFS, Piper Fatigue scale. a P-value was calculated by t-test.
Table 3
Comparison of the outcomes after meditation between groups.
Variables*
Group Intention to treat (N = 102) (Exp = 51, Con = 51) Pre (mean ± SD)
Post (mean ± SD)
Per protocol (N = 83) (Exp = 40, Con = 43) F
p-valuea Pre (mean ± SD)
Post (mean ± SD)
F
p-valuea
HADS Anxiety Depression
± ± ± ±
Exp Con Exp Con
6.84 6.20 7.16 6.82
2.54 2.76 3.39 3.56
Exp Con
3.94 ± 2.11 3.74 ± 1.74
5.51 6.28 5.76 6.19
± ± ± ±
3.12 3.73 3.12 4.15
4.772 .032
3.46 ± 2.02 4.34 ± 2.38
4.888 .030
± ± ± ±
4.981 .028
1.797 .184
6.90 5.98 7.25 6.54
± ± ± ±
2.46 2.69 3.09 3.47
5.33 6.28 5.72 6.19
± ± ± ±
3.03 3.73 2.89 4.15
5.050 .027
3.42 ± 1.98 4.34 ± 2.38
5.192 .025
± ± ± ±
4.294 .041
1.976 .164
PFS Fatigue EORTC QLQ C-30 Global quality of life Dyspnea
Exp Con Exp Con
57.00 58.33 18.00 16.99
± ± ± ±
19.88 19.37 25.39 26.14
70.29 62.02 12.32 17.83
18.31 21.69 20.32 16.82
2.943 .090
4.09 ± 1.94 3.80 ± 1.77 58.75 59.50 20.00 15.50
± ± ± ±
18.68 18.15 25.93 23.40
70.42 62.02 10.83 17.83
18.49 21.69 19.08 16.82
4.583 .035
Abbreviations: HADS, Hospital Anxiety Depression scale; EORTC QLQ C-30, European Organization for Research and Treatment of CancerQuality of Life Core-30; PFS, Piper Fatigue scale.; EXP, Experimental group; Con, Control group. * These are only significant variables. All variables in the study is shown in supplement table 1. a P-value was calculated by analysis of covariance adjusting for baseline outcome. P-value < 0.05 was considered statistically significant.
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy radiotherapies, and investigate whether it can be clinically applied to those patients. For the results, the anxiety level of the test group that received the meditation therapy revealed a significant reduction, but that of the control group was elevated. The result of the present study supported the previous study result,26—28 which reported the effectiveness of meditation in the reduction of anxiety levels in breast cancer patients. Although several previously performed meta-analytical review studies26,28 reported the effectiveness of meditation therapy in reducing the depression level of breast cancer patients, the present study did not show any significant change of depression level after receiving the meditation therapy in the test group. It could be observed from the results that the measured HADs scores in the test group and control group were in normal range by respectively recording 7.157 and 6.824 (a score of more than 8.0 indicates depression suspicious state),29 and showing no significant change before and after receiving the meditation therapy. Although there is no study that investigated depression by applying the same meditation therapy as the present study, it was reported that meditation showed to be effective in lowering stress and have a positive effect in patients’ mood.17 Therefore, it is considered to be necessary to conduct additional studies by selectively subjecting a depression-suspected patient group with more than HADs score of 8.0, or to conduct a study by modifying the study design. It was shown that the fatigue level of the control group increased, whereas the fatigue level of the test group that was given meditation therapy decreased, whereby investigating the effectiveness of meditation in improving fatigue; these results were consistent with the results from other meditation study.10,30,31 Although the results of our study were contradictory to the results obtained by Kieviet-Stijnen et al.,30 in which cancer patients were given meditation therapy for 8 weeks and the effects of meditation on fatigue were studied, compared to the results of another study on meditation10 that looked at the effects of meditation on fatigue, the results of our study were similar. The two studies both applied the same meditation therapy of mindfulness meditation on cancer patients; however, there were differences between these two studies. In the case of the study by Carlson and Garland,10 light yoga movements were included, and this was similar to the meditation applied in our study; however, in the study by Kieviet-Stijnen et al.,30 movements were not included, and this was the difference with the meditation of our study. In addition, in studies that consisted of meditation and movements for women with breast cancer and PSIT (PsychoSpiritual Integrative Therapy) was applied, or in study32 that applied — albeit not for cancer patients — meditation along with repetitive finger movements for patients with memory loss, the results that suggested the effectiveness of meditation against fatigue were consistent with our study results. Other than that, although no direct measurement of fatigue was made, there is a study that reported meditation having a positive effect in higher energy and physical function.27 In fact, among the previous studies, random studies of meditation’s effects on fatigue levels of cancer patients
385
are not that commonly found. Nevertheless, several studies have reported a link between cancer-related fatigue and increased levels of depression, anxiety, and mood disturbance.6,33,34 Our study was predicated upon one thought: If meditation can positively influence cancer patients from an emotional aspect, then would not meditation be effective in improving fatigue as well? Moreover, in regard to the characteristics of the Brain Wave Vibration meditation applied in this study, there is a significant amount of rhythmic physical movements that are included. As such, we are of the belief that, due to regular physical activities, the health of study participants improved and this has contributed in alleviating the degree of fatigue as well. Finally, the global QOL that was measured by using the EORTC QLQ C-30 resulted to show a significant improvement by recording the QOL scores higher than 10 points. Among the other variables, according to the EORTC QLQ C30 scoring guideline for dyspnea, the test result could be interpreted that the change of life quality for the meditation therapy received test group was ‘‘very much’’ compared to that of the control group.35 Cancer diagnosis and therapy are the difficult processes for cancer patients. Especially, in the cases of breast cancer patients, those of distresses such as anxiety and depression are increased with the progression of radiotherapies.2 In addition, fatigue is commonly experienced by the 30—80% of the radiotherapy receiving cancer patients.4 It could be included as one of the most commonly experienced side effects in breast cancer suffering female patients who receive a supplementary radiotherapy after having surgery.4,5 Fatigue in cancer patients was also found to be increased with the progression of radiotherapy, which reaches the maximum level at the patients’ final week, and often has a negative effect in patients’ life quality6,7 . Therefore, even if the present meditation therapy has no effect on depression, other functions, and symptomatically related variables, it could be a clinically meaningful therapy from the perspective that the therapy reduced the anxiety and fatigue levels of radiotherapy receiving breast cancer patients and had positive effects on patients’ life quality. However, since the present study cannot exclude dynamic effects in the cancer patient group by the use of non-intervention control group, there should be a caution for the expanded interpretation of the present study result. During the process of this study, we researchers were able to hear about a variety of meditation experiences from the patients. During meditation, some participants confessed that it was very difficult for them emotionally at the beginning stage of participation in meditation, which was due, in part, to the fact that seeing other cancer patients in the same room reminded them of their being cancer patients themselves. This is consistent with the literature that stated when meditation is administered for the first time, because of the realization about the reality, the subject actually experiences anxiety.36 On the contrary, two patients who had similar initial reactions to the experience stated that, as the sessions continued, their comfort level improved. Additionally, one patient confessed that, ever since she had been diagnosed with cancer and underwent surgery and radiation therapy, she was not able to cry during the following 8 months; however, after she started
386 participating in meditation, she was finally able to cry for the first time. This is, in our opinion, attributable to the unconscious repression and avoidance of a variety of emotions including fear and anxiety by the patient, but through meditation the patient is able to face her inner self and utilize the channel of expression of her emotions. As such, in order to obtain the information and effects of a variety of negative thoughts that patients, who are being exposed to meditation for the first time, could experience at the onset of a meditation experiment, it would be advisable for the involved medical professionals to inform the patients that an ample amount of time is required for them to experience the benefits of meditation. In addition, unlike the general public, for women with breast cancer, sudden arm movements may be too stressful. Therefore, a special care is called for when deciding on the relaxation calisthenics before meditation. Through this study, we were of the thought that Brain Wave Vibration meditation that includes non-stressful rhythmic movements is effective for women with breast cancer who are undergoing radiation therapy in improving their anxiety, fatigue, and global quality of life. It can be shown that our study is one that demonstrates the possibility of utilization of meditation in clinical settings as non-invasive intervention treatment for cancer patients.
Limitations One limitation of the study was limited meditation sessions. Although they participated in the study for6 weeks, they only did a maximum of 12 sessions. It was not enough for them to change significantly. I addition, since this study was limited to studying only women undergoing radiation therapy, we could not follow up the long-term effects of meditation. Secondly, we could not consider the effects of group dynamics because there was not an adequate control group. It might be difficult to investigate the real effects of this study and the weakened effects of the meditation group. Based on the limitations of this study, we would like to make the following suggestions: further studies should conduct the long-term effects of the meditation with a placebo control group. In addition, it should be conducted by diversifying the types of cancers and treatment. Also, we suggest that future studies should include physiological variables.
Conclusions We conclude that the BWV meditation significantly decreased anxiety, fatigue, and improved global quality of life for breast cancer patients undergoing radiotherapy. These findings indicate that the meditation could be a positive and non-invasive intervention for breast cancer patients during radiotherapy.
Conflict of interest None declared.
Y.H. Kim et al.
Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/ j.ctim.2013.06.005.
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Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy 18. Shim JY, Kim Yh. Effects of brain respiration training on electroencephalogram and depressive state in old women. Korean Society of Sport Psychology 2006;17(4):117—32. 19. Han JK, Lim SM. The effects of brain respiration meditation and cognitive therapy on depressed high school students. The Korean Journal of Counseling and Psychotherapy 2005;17(4):855—76. 20. Jung YH, Kang DH, Jang JH, Park HY, Byun MS, Kwon SJ, Jang GE, Lee US, An SC, Kwon JS, et al. The effects of mind-body training on stress reduction, positive affect, and plasma catecholamines. Neuroscience Letters 2010;479(2): 138—42. 21. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatrica Scandinavica 1983;67(6):361—70. 22. Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised piper fatigue scale: psychometric evaluation in women with breast cancer. Oncology Nursing Forum 1998;25(4):677—84. 23. Lee EH. Construct validity of the revised piper fatigue scale in Korean women with breast cancer. Journal of Korean Academy of Nursing 1999;29(3):485—93. 24. EORTC; 2003. Available from: http://www.eortc.be/home/qol/ 25. Kim SH, Kim YH, Kim HJ, Lee SH, Yu SO. The effect of laughter therapy on depression, anxiety, and stress in patients with breast cancer undergoing radiotherapy. Journal of Korean Oncology Nursing 2009;9(2):155—62. 26. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a metaanalytic review. Journal of Consulting and Clinical Psychology 2010;78(2):169. 27. Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE, et al. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psycho-Oncology 2009;18(12):1261—72.
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28. Matchim Y, Armer JM. Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Oncology Nursing Forum: Oncology Nursing Society 2007:1059—66. 29. Olssøn I, Mykletun A, Dahl A. The Hospital Anxiety and Depression Rating Scale: a cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry 2005;5(1):46. 30. Kieviet-Stijnen A, Visser A, Garssen B, Hudig W. Mindfulnessbased stress reduction training for oncology patients: patients’ appraisal and changes in well-being. Patient Education and Counseling 2008;72(3):436—42. 31. Oh B, Butow P, Mullan B, Clarke S, Beale P, Pavlaki M, Kothe E, Lam L, Rosenthal D, et al. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Annals of Oncology 2010;21(3):608—14. 32. Moss AS, Wintering N, Roggenkamp H, Khalsa DS, Waldman MR, Monti D, Newberg AB, et al. Effects of an 8-week meditation program on mood and anxiety in patients with memory loss. Journal of Alternative and Complementary Medicine 2012;18(1):48—53. 33. Okuyama T, Akechi T, Kugaya A, Okamura H, Imoto S, Nakano T, Mikami I, Hosaka T, Uchitomi Y, et al. Factors correlated with fatigue in disease-free breast cancer patients: application of the Cancer Fatigue Scale. Supportive Care in Cancer 2000;8(3):215—22. 34. Brown DJF, McMillan DC, Milroy R. The correlation between fatigue, physical function, the systemic inflammatory response, and psychological distress in patients with advanced lung cancer. Cancer 2004;103(2):377—82. 35. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology 1998;16(1):139—44. 36. Bauer-Wu S. Mindfulness meditation. Oncology (Williston Park) 2010;24(10 Suppl.):36—40.
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Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer夽 Yeon Hee Kim a,1, Hwa Jung Kim b,1, Seung Do Ahn c, Yun Jeong Seo d, So Hee Kim a,∗ a
Department of Nursing, Asan Medical Center, Seoul, Republic of Korea Department of Epidemiology and Biostatistics, Asan Medical Center, Seoul, Republic of Korea c Department of Radiation Oncology, Asan Medical Center, Seoul, Republic of Korea d Dahnworld Korea, Seoul, Republic of Korea Available online 6 July 2013 b
KEYWORDS Breast cancer; Meditation; Anxiety; Fatigue; Quality of life
Summary Objective: To investigate the effects of meditation on anxiety, depression, fatigue, and quality of life in women who are receiving radiation therapy for breast cancer. Design: Randomized, non-program controlled, parallel intervention clinical trial. Setting: The ASAN Cancer Center located in Seoul, Korea. Intervention: The subjects of this study included 102 female breast cancer patients who had undergone breast-conserving surgery; these female patients were randomized into equally assigned meditation control groups, with each group consisting of 51 patients. The test group received a total of 12 meditation therapy sessions during their 6-week radiation therapy period, and the control group underwent only a conventional radiation therapy. Outcome: The tools used to evaluate the effects of meditation were Hospital Anxiety and Depression scale, Revised Piper Fatigue scale, and European Organization for Research and Treatment of Cancer-Quality of Life Core-30. The results were analyzed based on the principles of intention-to-treat analysis, and, as a corollary analysis, per-protocol analysis was conducted. Results: The breast cancer patients who received meditation therapy compared with the nonintervention group saw improvements in reduction of anxiety (p = .032), fatigue (p = .030), and improvement in global quality of life (p = .028). Conclusions: Based on the results of this study, an affirmation can be made that meditation can be used as a non-invasive intervention treatment for improving fatigue, anxiety, quality of life, and emotional faculties of women with breast cancer. © 2013 Elsevier Ltd. All rights reserved.
夽
The Korea Breast Cancer Foundation (KBCF) funded this study. Corresponding author at: 1F West Bldg., Cancer Education Center, Asan Medical Center, 88, Olympic-ro, Songpa-gu, Seoul 138-736, Republic of Korea. Tel.: +82 2 3010 1127; fax: +82 2 3010 1158. E-mail address: [email protected] (S.H. Kim). 1 Both authors contributed equally to this study. ∗
0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.06.005
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Introduction Although radiation therapy, which is conducted as an adjuvant treatment after a breast-conserving surgery, lowers the rate of recurrence and increases disease-free survival rate.1 The patients are subject to experiencing several side effects during the treatment process itself. In particular, along with various physical side effects, as a result of long-term treatment and uncertainty, emotional and social problems such as anxiety and depression can be experienced.2 Additionally, in cases of women with breast cancer, emotional symptoms including depression have been shown to become aggravated depending on the progress of radiation therapy.3 In addition, cancer-related fatigue is a common side effect appealed by 30—80% of cancer patients receiving radiation therapy, regardless of the irradiation area.4 Also, cancer-related fatigue is one of the most common side effects experienced by women breast cancer patients receiving post-surgery adjuvant radiation therapy.5 According to previous studies, in cases of women with breast cancer undergoing radiation therapy treatment, as their treatment progressed, their fatigue levels continued to worsen.6,7 In the last week of treatment their fatigue levels reached the maximum level, and 3—6 months after the completion of treatment the fatigue levels were found to be reverting back to the pretreatment levels; also, the patient’s quality of life was found to be negatively affected.6,7 Moreover, according to the results of a study that examined the symptom clusters associated with treatment for patients with breast cancer, because their depressed mood, cognitive impairment, fatigue, insomnia, and pain all appeared to be related, it is necessary to consider the potential correlation among the symptoms when assessing and planning for the management in breast cancer patients.8 As shown, fatigue, anxiety, and depression are typical psychological and physical side effects experienced by women with breast cancer, and it can be stated that these symptoms require aggressive intervention along with treatment. Meditation is one of the alternative therapies soften practiced in many fields as a non-pharmacological intervention therapy,9 and it is known to be helpful in terms of controlling depression, anxiety, sleep disturbances, pain, fatigue, and stress levels in cancer patients.10,11 Recently (in Korea as well), as an alternative therapy for cancer patients, research on meditation is being attempted, In the case of mindfulness meditation, it is currently one of the methods included as part of the non-pharmacological recommendations of the Version 112 Distress Management Recommendations of the Korea National Cancer Center for the improvement of quality of life in cancer patients. Meditation is diverse in its types and has been developed to suit local features and physical characteristics; therefore, in order for mediation to be studied in Korea so that it can be applied in clinical settings, it would be preferable to use traditional Korean discipline techniques.13 Brain Wave Vibration (BWV) meditation was previously known as ‘‘Body and Brain Holistic Fitness Training’’ or ‘‘Dahn yoga’’14 and is one of the traditional meditation methods in Korea. BWV is believed to be most beneficial when practiced as part of a holistic fitness class in combination with other related yoga-style exercises.15
Y.H. Kim et al. This meditation was developed in South Korea by Il-Chi Lee in the 1980s, and is designed to optimize body and brain health, as well as rebalance the energy systems of the body.16 Although the Brain Wave Vibration meditation has not been attempted on cancer patients, several previous studies17—19 reported its effectiveness in reducing anxiety and dealing with stress. According to a previous study,15 Brain Wave Vibration meditation reported improvement in depression and sleep latency. In the study, ordinary college students were divided into 3 groups and were administered with the Brain Wave Vibration meditation, Iyengar yoga, and mindfulness meditation; the results of these experiments showed that the Brain Wave Vibration group experienced improvement in depression and sleep latency. In another randomized study on the general public, it showed that there were significant effects in reducing stress and enhancing overall positive outlook.20 Based on all of this, by applying the Brain Wave Vibration meditation on women with breast cancer in this study, we attempted to analyze the effects on their anxiety, depression, fatigue, and quality of life.
Participants and methods This study is an open-label, randomized clinical trial investigating the effects that meditation has on anxiety, depression, fatigue, and quality of life in women who are receiving radiation therapy for breast cancer. This study was undertaken only after obtaining approval (IRB approval number: S2011-0179-0002) from the IRB of Asan Medical Center in Seoul, Korea; all participants took part in the study after providing written consent.
Participants Eligible participants included women aged 20 or over with breast cancer, all of whom started radiation therapy after a breast conserving operation, understand the purpose of the study, and agreed to participate. Exclusion criteria included receiving psychiatric treatment, or patients with metastasis or recurrence. Also, those who participated in another study related to distress or quality of life were excluded. The participants in the study were comprised of 102 female cancer patients who were receiving radiation therapy after breast conserving operation at the outpatient unit of ‘‘Asan Medical Center’’ general hospital located in Seoul, Korea.
Intervention The meditation used in this study is Brain Wave Vibration meditation. This is based on the Korean traditional exercise ‘‘Danhak’’ which is a traditional Korean training technique. ‘‘Danhak’’ transformed into a training system that promotes change in mind and body with the brain at the center, and is comprised of simple movements and techniques so that anyone can use it.14,18 This is a modern brain health technique that combines simple movements, such as lightly shaking one’s head side-to-side, movements of a part of the
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy
Fig. 1
381
Weekly Meditation Topics
body in a rhythmic fashion, as well as music, action, and positive messages.14,16 In particular, it is a form of meditation with movements that induce focusing on the senses of the body while relaxing the mind and body and relieving negative thoughts in the body through natural rhythmic movements.16 In this study, the test group participated in meditation therapy twice a week during the 6-weeks of radiation therapy period, and the control group underwent the usual radiation-only therapy. The meditation therapy used in this study consisted of 60-min sessions twice a week, and the test group received a total of 12 sessions at twice a week for 6-weeks. This program was conducted for 6-weeks using different topics every week, and the program configuration is shown in Fig. 1. There was no intervention for control group during the study. After the study, we opened same meditation program, and gave them the opportunity to participate.
Outcome measurements and data collection The demographic information and health history of the study participants were collected through their medical records. Data collection for the analysis of the effects of meditation was conducted using a self-reporting questionnaire. The test and control groups were measured within 1-week prior to the commencement of radiation therapy for their anxiety, depression, fatigue, and quality of life status. In the case of the test group, data was collected at the completion of the 6-week radiation therapy and meditation program, and for the control group, they were also tested at the completion of the 6-week radiation therapy. For measuring anxiety and depression, the Hospital Anxiety and Depression scale (HADS)21 was used. The HADS has a total of 14 questions, in which the 7 odd-numbered questions had sub-scales related to anxiety (HAD-A) and the 7 even-numbered questions had sub-scales related to depression (HAD-D). Each question was on a 4-point scale (range of 0—3 points). For measuring fatigue, the Revised Piper Fatigue scale22,23 was used as a tool. There were a total of 19 questions in the questionnaire, and each question was on an 11-point scale (range of 0—10 points). The higher the score, the higher the fatigue level. For measuring the quality of life, a Korean version of the EORTC QLQ-C3024 that consisted
of 30 questions was used. The EORTC QLQ-C30 consisted of 15 scales, including the global quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social) and 8 symptomatic scales (including fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single item (financial difficulties). Of the EORTC QLQ-C30 items concerning the global QOL and functional scale, a higher score means a higher QOL; whereas, for the symptomatic scale and the single item, a higher score means a lower QOL.
Sample size We hypothesized that the meditation changes anxiety and depression levels compared to a control group; according to a previous study,25 the mean difference of anxiety and depression in the experimental group and control group were −1.74 ± 2.49, −.41 ± 2.25, and −2.58 ± 2.75, and −.04 ± 2.08, respectively. The group sample size (51 participants each) achieved 80% power to the similar difference of the previous study25 , with a significance level of .05 using two-sided independent two group t-test (G*Power 3.1 program).
Randomization The study participants, in the order of their agreement to participation in the study, were issued control numbers after consultation. Based on the control numbers, random numbers were generated by the website program — http://randomization.com/. A block of 4 would contain 2A and 2B with a ratio of 1:1. Stratification factors were based on whether the patient subjects had received chemotherapy prior to radiation therapy. One of the authors who did not have contact with patients managed the random numbers.
Statistical methods The primary outcome was a change in anxiety and depression after the intervention in the intention-to-treat (ITT) population. The secondary outcome was change in quality of life. This study was designed to detect between-group
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Y.H. Kim et al.
Fig. 2 Flow chart of the study. Legend: ITT, Intention-To-Treat; PP, Per Protocol.
differences after meditation, a power of 80%, and a type I error rate of 5%. The primary analysis was ITT analysis and involved all patients who were randomly assigned. The per-protocol (PP) analysis was performed as a secondary analysis, and involved participants who participated in more than 9 sessions out of total 12 sessions (Fig. 2). We used an analysis of covariance (ANCOVA) for the measurement of outcomes. The ANCOVA model included as covariates. The ANCOVA model included baseline outcomes as covariates. Baseline measurements were expressed as means and SDs, with independent t-tests used for between-group comparisons of continuous variables, and the fisher’s exact test or Chi-square used for between-group comparisons of categorical variables. The data was analyzed with SPSS 18.0, and a significance level of hypothesis testing was set for p < .05.
Results A total of 252 potential candidates were interviewed and, among these, 102 patients agreed to participate in the study. The number of participants in each group was 51 patients. They were recruited during the period of about 3 months from April 27, 2011 to July 30, 2011. The number of ITT analysis included 51 patients in each group (Fig. 2). There were 40 patients in the meditation group and 43 patients in the control group for the PP analysis. Baseline demographic and clinical characteristics for two groups showed no difference at the 5% significance level except for the emotional function, cognitive function, and social function of the EORTC QLQ-C30 items (Tables 1 and 2).
Anxiety, depression, fatigue, and quality of life In the case of ITT analysis, the result of the effects that meditation has on anxiety, depression, fatigue, and quality of life in women with breast cancer receiving radiation therapy showed the following: the meditation group decreased their anxiety by 1.33 points, whereas the control group increased by .08 points, significantly (p = .032); Also the meditation group decreased their fatigue by .48 points, whereas the control group increased by .60 points (p = .030); however, the change in depression was not significant (p = .184). These results were repeated using the PP analysis and our hypothesis of meditation’s being effective for improving anxiety and fatigue (Table 3). As a result of ITT analysis on the items that correspond to EORTC QLQ-C30, in terms of the global QOL, the meditation group significantly increased 13.29 points, whereas the control group increased 3.69 points (p = .028). These results were also the same using the PP analysis (p = .041) (Table 3). Dyspnea of the meditation group showed a decrease, whereas the control group showed an increase. It was not statistically significant in the ITT analysis (p = 0.090), while it was significant in the PP analysis (p = 0.035) (Table 3). In conclusion, the results of ITT and PP analysis were very similar.
Discussion The present study aimed to investigate the effects of mediation on anxiety, depression, fatigue, and quality of life by subjecting breast cancer patients who currently receive
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy Table 1
383
Baseline characteristics of study participants.
Characteristics
Experimental group (N = 51) N(%), Mean±SD
Control group (N = 51) N(%), Mean±SD
p-valuea
Age
48.12 ± 7.06
46.86 ± 7.74
.394
Level of education High school College Graduate school
25 (49.0%) 21 (41.2%) 5 (9.8%)
29 (56.9%) 19 (37.3%) 3 (5.9%)
.656c
Marital status Married Unmarried Widowed The others
44 (86.3%) 3 (5.9%) 2 (3.9%) 2 (3.9%)
43 (84.3%) 4 (7.8%) 2 (3.9%) 2 (3.9%)
1.000c
Religion Christian Catholic Buddhist None The others
15 (29.4%) 6 (11.8%) 14 (27.5%) 15 (29.4%) 1 (2.0%)
17 (35.4%) 6 (12.5%) 9 (18.8%) 14 (29.2%) 2 (4.2%)
.829c
Regular activity No Yes
17 (33.3%) 34 (66.7%)
15 (29.4%) 36 (70.6%)
.670b
Economic burden Severe Mild None
2 (3.9%) 24 (47.1%) 25 (49.0%)
3 (5.9%) 17 (33.3%) 31 (60.8%)
.361c
Time since diagnosis (months)
5.25 ± 2.45
5.92 ± 3.42
.261
Stage of disease 0 I II III
7 (13.7%) 22 (43.1%) 20 (39.2%) 2 (3.9%)
5 (9.8%) 20 (39.2%) 25 (49.0%) 1 (2.0%)
.725c
Molecular subtype Luminal A Luminal B HER2+ Triple-negative
25 (49.0%) 5 (9.8%) 8 (15.7%) 13 (25.5%)
35 (68.6%) 4 (7.8%) 4 (7.8%) 8 (15.7%)
.216c
Surgery Rt. BCO Lt. BCO Both BCO
22 (43.1%) 29 (56.9%) 0 (0.0%)
22 (43.1%) 28 (54.9%) 1 (2.0%)
1.000c
Chemotherapy AC ACT Not done
13 (25.5%) 19 (37.3%) 19 (37.3%)
19 (37.3%) 11 (21.6%) 21 (41.2%)
.187c
Hormonal therapy Tamoxifen/toremifen Tamoxifen + goserelin Aromatase inhibitor Not done
21 (41.2%) 9 (17.6%) 8 (15.7%) 13 (25.5%)
18 (35.3%) 9 (17.6%) 4 (7.8%) 20 (39.2%)
.384b
HER2 targeted therapy Herceptin Not done
3 (5.9%) 48 (94.1%)
8 (15.7%) 43 (84.3%)
.110b
Abbreviations: BCO, breast conserving operation; AC, doxorubicin + cyclophosphamide; ACT, doxorubicin + cyclophosphamide + docetaxel. a P-value was calculated by t-test, Chi -square test b or Fisher’s exact test c .
384 Table 2
Y.H. Kim et al. Homogeneity of dependent variables before meditation.
Variables
Experimental group (N = 51) Mean ± SD
p-valuea
Control group (N = 51) Mean ± SD
HADS Anxiety Depression
6.84 ± 2.54 7.16 ± 3.38
6.20 ± 2.76 6.82 ± 3.56
.221 .629
PFS Fatigue
3.94 ± 2.11
3.74 ± 1.74
.603
± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
.733 .342 .303 .001 .045 .048 .352 .352 .352 .845 .115 .193 .948 .431 .132
EORTC QLQ C-30 Global quality of life Physical function Role function Emotional function Cognitive function Social function Fatigue Nausea and vomiting Pain Dyspnea Insomnia Appetite loss Constipation Diarrhea Financial difficulties
57.00 68.93 65.00 65.17 67.33 63.33 42.89 10.00 27.67 18.00 35.33 31.33 16.00 11.33 22.67
± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
19.88 18.74 24.80 19.76 23.32 24.51 23.22 14.68 19.52 25.39 28.10 28.89 24.50 19.76 25.59
58.33 72.29 69.94 77.45 75.82 72.22 39.00 10.78 24.84 16.99 26.80 24.18 15.69 8.50 15.69
19.37 16.51 23.10 16.18 18.35 19.91 18.38 15.21 23.18 26.14 25.84 25.89 23.43 16.12 20.39
Abbreviations: HADS, Hospital Anxiety Depression scale; EORTC QLQ C-30, European Organization for Research and Treatment of CancerQuality of Life Core-30; PFS, Piper Fatigue scale. a P-value was calculated by t-test.
Table 3
Comparison of the outcomes after meditation between groups.
Variables*
Group Intention to treat (N = 102) (Exp = 51, Con = 51) Pre (mean ± SD)
Post (mean ± SD)
Per protocol (N = 83) (Exp = 40, Con = 43) F
p-valuea Pre (mean ± SD)
Post (mean ± SD)
F
p-valuea
HADS Anxiety Depression
± ± ± ±
Exp Con Exp Con
6.84 6.20 7.16 6.82
2.54 2.76 3.39 3.56
Exp Con
3.94 ± 2.11 3.74 ± 1.74
5.51 6.28 5.76 6.19
± ± ± ±
3.12 3.73 3.12 4.15
4.772 .032
3.46 ± 2.02 4.34 ± 2.38
4.888 .030
± ± ± ±
4.981 .028
1.797 .184
6.90 5.98 7.25 6.54
± ± ± ±
2.46 2.69 3.09 3.47
5.33 6.28 5.72 6.19
± ± ± ±
3.03 3.73 2.89 4.15
5.050 .027
3.42 ± 1.98 4.34 ± 2.38
5.192 .025
± ± ± ±
4.294 .041
1.976 .164
PFS Fatigue EORTC QLQ C-30 Global quality of life Dyspnea
Exp Con Exp Con
57.00 58.33 18.00 16.99
± ± ± ±
19.88 19.37 25.39 26.14
70.29 62.02 12.32 17.83
18.31 21.69 20.32 16.82
2.943 .090
4.09 ± 1.94 3.80 ± 1.77 58.75 59.50 20.00 15.50
± ± ± ±
18.68 18.15 25.93 23.40
70.42 62.02 10.83 17.83
18.49 21.69 19.08 16.82
4.583 .035
Abbreviations: HADS, Hospital Anxiety Depression scale; EORTC QLQ C-30, European Organization for Research and Treatment of CancerQuality of Life Core-30; PFS, Piper Fatigue scale.; EXP, Experimental group; Con, Control group. * These are only significant variables. All variables in the study is shown in supplement table 1. a P-value was calculated by analysis of covariance adjusting for baseline outcome. P-value < 0.05 was considered statistically significant.
Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy radiotherapies, and investigate whether it can be clinically applied to those patients. For the results, the anxiety level of the test group that received the meditation therapy revealed a significant reduction, but that of the control group was elevated. The result of the present study supported the previous study result,26—28 which reported the effectiveness of meditation in the reduction of anxiety levels in breast cancer patients. Although several previously performed meta-analytical review studies26,28 reported the effectiveness of meditation therapy in reducing the depression level of breast cancer patients, the present study did not show any significant change of depression level after receiving the meditation therapy in the test group. It could be observed from the results that the measured HADs scores in the test group and control group were in normal range by respectively recording 7.157 and 6.824 (a score of more than 8.0 indicates depression suspicious state),29 and showing no significant change before and after receiving the meditation therapy. Although there is no study that investigated depression by applying the same meditation therapy as the present study, it was reported that meditation showed to be effective in lowering stress and have a positive effect in patients’ mood.17 Therefore, it is considered to be necessary to conduct additional studies by selectively subjecting a depression-suspected patient group with more than HADs score of 8.0, or to conduct a study by modifying the study design. It was shown that the fatigue level of the control group increased, whereas the fatigue level of the test group that was given meditation therapy decreased, whereby investigating the effectiveness of meditation in improving fatigue; these results were consistent with the results from other meditation study.10,30,31 Although the results of our study were contradictory to the results obtained by Kieviet-Stijnen et al.,30 in which cancer patients were given meditation therapy for 8 weeks and the effects of meditation on fatigue were studied, compared to the results of another study on meditation10 that looked at the effects of meditation on fatigue, the results of our study were similar. The two studies both applied the same meditation therapy of mindfulness meditation on cancer patients; however, there were differences between these two studies. In the case of the study by Carlson and Garland,10 light yoga movements were included, and this was similar to the meditation applied in our study; however, in the study by Kieviet-Stijnen et al.,30 movements were not included, and this was the difference with the meditation of our study. In addition, in studies that consisted of meditation and movements for women with breast cancer and PSIT (PsychoSpiritual Integrative Therapy) was applied, or in study32 that applied — albeit not for cancer patients — meditation along with repetitive finger movements for patients with memory loss, the results that suggested the effectiveness of meditation against fatigue were consistent with our study results. Other than that, although no direct measurement of fatigue was made, there is a study that reported meditation having a positive effect in higher energy and physical function.27 In fact, among the previous studies, random studies of meditation’s effects on fatigue levels of cancer patients
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are not that commonly found. Nevertheless, several studies have reported a link between cancer-related fatigue and increased levels of depression, anxiety, and mood disturbance.6,33,34 Our study was predicated upon one thought: If meditation can positively influence cancer patients from an emotional aspect, then would not meditation be effective in improving fatigue as well? Moreover, in regard to the characteristics of the Brain Wave Vibration meditation applied in this study, there is a significant amount of rhythmic physical movements that are included. As such, we are of the belief that, due to regular physical activities, the health of study participants improved and this has contributed in alleviating the degree of fatigue as well. Finally, the global QOL that was measured by using the EORTC QLQ C-30 resulted to show a significant improvement by recording the QOL scores higher than 10 points. Among the other variables, according to the EORTC QLQ C30 scoring guideline for dyspnea, the test result could be interpreted that the change of life quality for the meditation therapy received test group was ‘‘very much’’ compared to that of the control group.35 Cancer diagnosis and therapy are the difficult processes for cancer patients. Especially, in the cases of breast cancer patients, those of distresses such as anxiety and depression are increased with the progression of radiotherapies.2 In addition, fatigue is commonly experienced by the 30—80% of the radiotherapy receiving cancer patients.4 It could be included as one of the most commonly experienced side effects in breast cancer suffering female patients who receive a supplementary radiotherapy after having surgery.4,5 Fatigue in cancer patients was also found to be increased with the progression of radiotherapy, which reaches the maximum level at the patients’ final week, and often has a negative effect in patients’ life quality6,7 . Therefore, even if the present meditation therapy has no effect on depression, other functions, and symptomatically related variables, it could be a clinically meaningful therapy from the perspective that the therapy reduced the anxiety and fatigue levels of radiotherapy receiving breast cancer patients and had positive effects on patients’ life quality. However, since the present study cannot exclude dynamic effects in the cancer patient group by the use of non-intervention control group, there should be a caution for the expanded interpretation of the present study result. During the process of this study, we researchers were able to hear about a variety of meditation experiences from the patients. During meditation, some participants confessed that it was very difficult for them emotionally at the beginning stage of participation in meditation, which was due, in part, to the fact that seeing other cancer patients in the same room reminded them of their being cancer patients themselves. This is consistent with the literature that stated when meditation is administered for the first time, because of the realization about the reality, the subject actually experiences anxiety.36 On the contrary, two patients who had similar initial reactions to the experience stated that, as the sessions continued, their comfort level improved. Additionally, one patient confessed that, ever since she had been diagnosed with cancer and underwent surgery and radiation therapy, she was not able to cry during the following 8 months; however, after she started
386 participating in meditation, she was finally able to cry for the first time. This is, in our opinion, attributable to the unconscious repression and avoidance of a variety of emotions including fear and anxiety by the patient, but through meditation the patient is able to face her inner self and utilize the channel of expression of her emotions. As such, in order to obtain the information and effects of a variety of negative thoughts that patients, who are being exposed to meditation for the first time, could experience at the onset of a meditation experiment, it would be advisable for the involved medical professionals to inform the patients that an ample amount of time is required for them to experience the benefits of meditation. In addition, unlike the general public, for women with breast cancer, sudden arm movements may be too stressful. Therefore, a special care is called for when deciding on the relaxation calisthenics before meditation. Through this study, we were of the thought that Brain Wave Vibration meditation that includes non-stressful rhythmic movements is effective for women with breast cancer who are undergoing radiation therapy in improving their anxiety, fatigue, and global quality of life. It can be shown that our study is one that demonstrates the possibility of utilization of meditation in clinical settings as non-invasive intervention treatment for cancer patients.
Limitations One limitation of the study was limited meditation sessions. Although they participated in the study for6 weeks, they only did a maximum of 12 sessions. It was not enough for them to change significantly. I addition, since this study was limited to studying only women undergoing radiation therapy, we could not follow up the long-term effects of meditation. Secondly, we could not consider the effects of group dynamics because there was not an adequate control group. It might be difficult to investigate the real effects of this study and the weakened effects of the meditation group. Based on the limitations of this study, we would like to make the following suggestions: further studies should conduct the long-term effects of the meditation with a placebo control group. In addition, it should be conducted by diversifying the types of cancers and treatment. Also, we suggest that future studies should include physiological variables.
Conclusions We conclude that the BWV meditation significantly decreased anxiety, fatigue, and improved global quality of life for breast cancer patients undergoing radiotherapy. These findings indicate that the meditation could be a positive and non-invasive intervention for breast cancer patients during radiotherapy.
Conflict of interest None declared.
Y.H. Kim et al.
Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at http://dx.doi.org/10.1016/ j.ctim.2013.06.005.
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